Recruiting

Observational Study

Sponsor:

Maxx Orthopedics Inc

Code:

NCT06627699

Conditions

Knee Osteoarthristis

Total Knee Anthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total Knee Arthroplasty

Study Details

Brief summary:

In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.

Conditions

Knee Osteoarthristis

Total Knee Anthroplasty

Study ID

NCT06627699

Start date

Nov 1, 2025

Status verified date

Jun, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

Candidates for this registry must meet ALL of the following criteria:

  • Patient is > 18 years of age
  • Patient has failed attempts at non-operative conservative therapy
  • Patient has participated in the informed consent process and signed an IRB approved informed consent
  • Patient is scheduled to undergo unilateral or bilateral primary TKA of the knee

EXCLUSION CRITERIA:

Candidates will be excluded from the evaluation if ANY of the following apply:

  • Patients with previous TKA, UKA, HTO or knee fusion of the indicated knee
  • Patients that have undergone previous surgery of indicated knee for tumor, trauma or fracture
  • Evidence of active or suspected (systemic or local) infection at time of surgery
  • Other significant disabling problems from the musculoskeletal system than in the knee (i.e.: muscular dystrophy, polio, neuropathic joints)
  • Patients with or having; malignancy - active malignancy, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia and systemic lupus erythematosus
  • Patients with neuromuscular or neurosensory deficit
  • Women who are pregnant
  • Prisoner or transient
  • Recent history of known narcotic abuse
  • Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients receiving the Maxx Freedom Total Knee System for primary TKA

TARGETED PATIENTS Adult male and female patients greater than 18 years of age Candidate for primary TKA GENERAL EXCLUSIONS Active infection Revision / conversion TKA (Prior UKA or HTO)

Interventions

Total Knee Arthroplasty

Post-Market Surveillance of the Freedom Total Knee System for Primary TKA

Primary outcome measure

  • Device Survivorship [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Nach Dave, MS, RPh

732-718-1385nach.dave@maxxortho.com

Corey Perine, BS, MBA

215-432-4323corey.perine@maxxortho.com

Locations

Ascentist Healthcare

Recruiting

Leawood, Kansas, United States, 66211

Principal Investigator:

Andrew C Palmoisano, MD

South Texas Bone & Joint Institute

Recruiting

San Antonio, Texas, United States, 78249

Principal Investigator:

Siraj A Sayeed, MD

More Information

Sponsor

Maxx Orthopedics Inc

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Registry
  • Primary TKA
  • Total Knee Arthroplasty
  • Total Knee Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Maxx Orthopedics Inc on 2026-06-26.